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Table 3 Mortality in trials of IVIG for proven sepsis & septic shock in adults and children

From: The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial

Study Exptl n/N Ctrl n/N Relative Risk (95% CI Fixed) Weight
Standard IVIG vs placebo or no intervention, ACM
Chen 1996 2/28 1/28 2.00 [0.19, 20.82] 0.9%
De Simone 1988 7/12 9/12 0.78 [0.44, 1.39] 8.5%
Dominioni 1991 11/29 22/33 0.57 [0.34, 0.96] 19.3%
Grundmann 1988 15/24 19/22 0.72 [0.51, 1.03] 18.6%
Just 1986 6/13 9/16 0.82 [0.40, 1.70] 7.6%
Shenoi 1999 7/25 7/25 1.00 [0.41, 2.43] 6.6%
Weisman 1992 2/14 5/17 0.49 [0.11, 2.13] 4.2%
Subtotal 50/145 72/153 0.73 [0.57, 0.93] 65.8%
IgM-enriched IVIG vs placebo or no intervention, ACM
Erdem 1993 6/20 9/24 0.80 [0.34, 1.86] 7.7%
Haque 1988 1/30 6/30 0.17 [0.02, 1.30] 5.6%
Schedel 1991 2/27 9/28 0.23 [0.05, 0.97] 8.3%
Wesoly 1990 8/18 13/17 0.58 [0.33, 1.04] 12.6%
Subtotal 17/95 37/99 0.48 [0.30, 0.76] 34.2%
Total 67/240 109/252 0.64 [0.51, 0.80] 100%
  1. Review: Intravenous immunoglobulin for treating sepsis and septic shock
  2. Comparison: Polyclonal IVIG vs placebo or no intervention
  3. Outcome: All-cause mortality (ACM)